Brijjit® for Wound Closure in Gender Affirming Mastectomies

Overseen By Thomas Calahan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Accutane, Glucocorticoids, Immunosuppressants

Disqualifiers: Allergies, Scarring, Autoimmune, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Trial Summary

What is the purpose of this trial?

This trial will test Brijjit® FMTB in patients having double incision gender-affirming mastectomies. The device is used with sutures to improve how scars look and reduce healing issues. One side of the chest will use Brijjit® FMTB, while the other side will use standard care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you have used certain medications like Accutane, systemic glucocorticoids, or local immunosuppressants in the past year, you may not be eligible to participate.

Research Team

Rachel Bluebond-Langner

Principal Investigator

NYU Langone Health

Eligibility Criteria

Inclusion Criteria

Willingness to return for scheduled follow-up visits through 1 year post-operatively

English Speaking

Patient self-identifies as Transgender or Gender Expansive

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo bilateral double incision gender affirming mastectomies with one side receiving Brijjit® FMTB and the other serving as a control

1 day

1 visit (in-person)

Follow-up

Participants are monitored for scar appearance and wound complications using various assessment tools

12 months

Visits at baseline, week 2, week 4, week 6, week 8, 3-month, 6-month, and 12-month post-surgery

Treatment Details

Interventions

• Brijjit®

Participant Groups

Group I: Right chest with Brijjit® FMTB Experimental Treatment 1 Intervention

Patients will be assigned to have their right chest closure completed via Brijjit® FMTB. While the other chest (not selected for intervention) will be closed via traditional suture-based methods and will serve as an internal control.

Group II: Left chest with Brijjit® FMTB Experimental Treatment 1 Intervention

Patients will be assigned to have their left chest closure completed via Brijjit® FMTB. While the other chest (not selected for intervention) will be closed via traditional suture-based methods and will serve as an internal control.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+